U.S. patent number 9,993,357 [Application Number 14/627,574] was granted by the patent office on 2018-06-12 for prosthetic socket system.
This patent grant is currently assigned to OSSUR HF. The grantee listed for this patent is OSSUR HF. Invention is credited to Grimur Jonsson.
United States Patent |
9,993,357 |
Jonsson |
June 12, 2018 |
Prosthetic socket system
Abstract
A prosthetic socket system includes a socket having an inner
surface defining a socket cavity. A liner is adapted to receive a
residual limb and be removably positioned within the socket cavity.
A substantially sealed volume is defined between at least a portion
of an outer surface of the liner and a corresponding portion of the
inner surface of the socket. A wicking material is positionable in
the substantially sealed volume and at least one cooling fluid can
be carried by the wicking material. The at least one cooling fluid
is adapted to selectively boil within the substantially sealed
volume such that heat from the residual limb is converted into
latent heat of vaporization by the at least one cooling fluid for a
cooling effect.
Inventors: |
Jonsson; Grimur (Vogar,
IS) |
Applicant: |
Name |
City |
State |
Country |
Type |
OSSUR HF |
Reykjavik |
N/A |
IS |
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Assignee: |
OSSUR HF (Reykjavik,
IS)
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Family
ID: |
52596639 |
Appl.
No.: |
14/627,574 |
Filed: |
February 20, 2015 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20150238330 A1 |
Aug 27, 2015 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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61942939 |
Feb 21, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F
2/80 (20130101); A61F 2/78 (20130101); A61F
7/02 (20130101); A61F 2/7812 (20130101); A61F
2007/0069 (20130101); A61F 2007/0093 (20130101); A61F
2002/805 (20130101); A61F 2002/802 (20130101); A61F
2007/0239 (20130101); A61F 2007/0086 (20130101); A61F
2007/0068 (20130101); A61F 2007/0051 (20130101) |
Current International
Class: |
A61F
2/80 (20060101); A61F 7/00 (20060101); A61F
2/78 (20060101); A61F 7/02 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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10 2010 020 262 |
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Nov 2011 |
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DE |
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0363654 |
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Apr 1990 |
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EP |
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1875881 |
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Jan 2008 |
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EP |
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2014/182767 |
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Nov 2014 |
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WO |
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Other References
Iceross. Instructions for use. www.ossur.com. Copyright 2010. cited
by examiner .
O&PEdge. Prototype prosthetic cooling system wins UTSA
entrepreneurship competition. May 3, 2013. cited by examiner .
International Search Report from International Application No.
PCT/US2015/017026, dated May 8, 2015. cited by applicant .
International Search Report from PCT Application No.
PCT/US2016/048532, dated Oct. 26, 2016. cited by applicant.
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Primary Examiner: Sweet; Thomas J
Assistant Examiner: Bahena; Christie
Attorney, Agent or Firm: Workman Nydegger
Claims
What is claimed is:
1. A prosthetic socket system comprising: a prosthetic socket
including a sidewall, first and second apertures formed in the
sidewall and an inner surface defining a socket cavity; a liner
adapted to receive a residual limb of a user therein and to be
removably positioned within the socket cavity; a seal element
located between the liner and the inner surface of the socket, the
seal element defining a substantially sealed volume between at
least a portion of the liner and a corresponding portion of the
inner surface of the socket; a wicking material separate from the
liner and positioned in the substantially sealed volume, the
wicking material soaked with a supply of at least one cooling fluid
sized and configured such that the at least one cooling fluid is
available for boiling within the substantially sealed volume when a
temperature of the residual limb exceeds a temperature of the at
least one cooling fluid during physical activity of the user, the
wicking material repeatedly installable on the outer surface of the
liner and the at least one cooling fluid adapted to selectively
boil within the substantially sealed volume such that heat from the
residual limb is converted into latent heat of vaporization by the
at least one cooling fluid for a cooling effect, wherein the second
aperture is arranged in communication with an external supply of
the at least one cooling fluid, for delivering the at least one
cooling fluid to the wicking material within the substantially
sealed volume; and a pump operatively connected to the
substantially sealed volume via the first aperture, the pump
arranged to selectively create an elevated vacuum in the
substantially sealed volume.
2. The system of claim 1, wherein the at least one cooling fluid
comprises an alcohol.
3. The system of claim 1, wherein the elevated vacuum created by
the pump lowers a boiling temperature of the at least one cooling
fluid below an ambient temperature in the substantially sealed
volume.
4. The system of claim 1, wherein the elevated vacuum created by
the pump is dependent on one or more characteristics of the
user.
5. The system of claim 1, wherein the pump is arranged to exhaust
gases rising from the at least one cooling fluid from the
substantially sealed volume.
6. The system of claim 1, further comprising a one-way valve
fluidly connected with the first aperture.
7. The system of claim 1, wherein the seal element is formed on the
liner.
8. The system of claim 1, wherein the seal element is formed on the
socket.
9. A method of controlling moisture in prosthetic socket system,
the method comprising: positioning an air-impermeable liner on a
lower part of a residual limb of a user; positioning a wicking
material separate from the liner and on an outer surface of the
liner, the wicking material being repeatedly installable on the
outer surface of the liner; supplying at least one cooling fluid to
the wicking material; positioning the lower part of the residual
limb, the liner, the wicking material, and the at least one cooling
fluid in a socket cavity defined by a socket, wherein a
substantially sealed volume is defined between at least a portion
of the liner and a corresponding portion of the socket, the wicking
material carrying a supply of the at least one cooling fluid sized
and configured such that the at least one cooling fluid is
available for boiling within the substantially sealed volume when a
temperature of the residual limb exceeds a temperature of the at
least one cooling fluid; and applying a vacuum to the substantially
sealed volume for selectively boiling the cooling fluid within the
substantially sealed volume during physical activity of the user
such that heat from the residual limb is converted into latent heat
of vaporization by the at least one cooling fluid for a cooling
effect, wherein supplying the at least one cooling fluid to the
wicking material includes supplying the at least one cooling fluid
to the wicking material via an aperture defined in a sidewall of
the socket.
10. The method of claim 9, further comprising expelling gases
produced by boiling the at least one cooling fluid via the second
aperture defined in the socket.
11. The method of claim 9, wherein the at least one cooling fluid
comprises an alcohol.
12. The method of claim 9, wherein the at least one cooling fluid
comprises a mixture of an alcohol and water.
13. The method of claim 9, wherein the vacuum applied to the
substantially sealed volume exhaust gases raising from the at least
one cooling fluid from the substantially sealed volume.
14. The method of claim 9, further comprising a seal element
positionable between the liner and the socket, wherein the seal
element at least in part defines the substantially sealed
volume.
15. The method of claim 14, wherein the seal element is formed on
the liner.
16. The method of claim 14, wherein the seal element is formed on
the socket.
Description
TECHNICAL FIELD
The disclosure relates to a prosthetic socket system for heat and
perspiration management.
BACKGROUND
Prosthetic liners made of solid elastomer like silicone, copolymer
gel, or polyurethane have been commercially available and used for
a number of years as the media next to the skin in the majority of
lower extremity prostheses.
Such liners have solved many issues like friction and pressure
distribution; however, it has been difficult to achieve effective
heat and sweat management when using a non-porous interface. For
instance, moisture (e.g. sweat or condensation) within the liner
can adversely affect limb health. Moisture decreases the friction
suspending the liner on the residual limb. This can cause a
pistoning action, which describes the relative movement between the
liner and the residual limb.
Excessive limb pistoning tends to lead to friction-related injuries
such as friction blisters and skin irritation. It also creates the
potential for catastrophic failure of the suspension of the limb.
Problems such as dermatitis and infection are also common,
particularly if the liner and residual limb are not cleaned
appropriately or frequently.
Attempts have been made to incorporate elements such as drain
systems, heat exchangers, and semiconductors into known liners
and/or prostheses to more effectively remove heat and sweat from
the liner interface, yet, such designs are relatively complex,
bulky, costly, and inevitably prohibit their use with a large
majority of users.
To prevent such problems and to maintain secure adherence, users or
amputees are currently required to manage the build-up of sweat in
the liner themselves. They regularly have to remove their
prosthesis to empty accumulated sweat and dry their limb.
There is thus a need for a prosthetic socket system that provides
simple, comfortable, and effective heat and moisture management
without removal of components of the system.
SUMMARY
The disclosure describes various embodiments of a prosthetic socket
system providing simple, comfortable, and effective heat
management, without the bulk and complexity of conventional heat
management elements in known prosthetic socket systems. The
embodiments can manage the build-up of sweat in a liner with heat
management features that are easily and conveniently maintained,
adjusted, and/or controlled without having to remove components
from a user's prosthetic socket system.
The embodiments described can include a prosthetic system having a
socket with an inner surface defining a socket cavity. A liner is
adapted to receive a residual limb therein and to be removably
positioned within the socket cavity. A substantially sealed volume
is defined between at least a portion of the outer surface of the
liner and a corresponding portion of the inner surface of the
socket. A wicking material can be positioned in the substantially
sealed volume and at least one cooling fluid is carried by the
wicking material.
The at least one cooling fluid is adapted to selectively boil
within the substantially sealed volume such that heat from the
residual limb is converted into latent heat of vaporization by the
at least one cooling fluid, extracting the heat for a cooling
effect. This reduces sweating of the limb and the likelihood of
friction-related injuries and skin irritation. Furthermore, it does
so without the need of expensive and costly heat removal and/or
draining elements as in the prior art.
The boiling point of the at least one cooling fluid can be selected
or controlled to be higher or lower than one or more different
temperature limits within the substantially sealed volume. This can
help maintain the temperature of at least the distal end of the
residual limb within a desired range and/or control the timing and
level of heat removal achieved by the at least one cooling
fluid.
According to a variation, a pump is operatively connected to the
substantially sealed volume via a first aperture defined in the
socket. The pump can create an elevated vacuum environment in the
substantially sealed volume. This advantageously exhausts gases or
vapors from the substantially sealed volume, which, in turn,
removes additional energy or pressure buildup (e.g. kinetic energy
created by the release of gases or vapors from the boiling cooling
fluid), enhancing the cooling effect of the system.
This elevated vacuum environment can also lower the saturation
vapor pressure, lowering the boiling point of the at least one
cooling fluid. The pump can thus vary the boiling point of the at
least one cooling fluid to remove heat from the residual limb,
producing a cooling effect for the user on demand or when it is
needed most. The pump can also be used to regulate the temperature
of the residual limb during physical activities.
According to a variation, the socket defines a second aperture in
fluid communication with the substantially sealed volume. The
second aperture can be coupled to a one-way valve that allows the
at least one cooling fluid to be introduced into the substantially
sealed volume. This advantageously allows the at least one cooling
fluid to be supplied and/or replenished to the wicking material
after the prosthetic socket system is positioned on the residual
limb, without having to remove components from the system, making
the system easier and more comfortable to use.
Additional features and advantages of embodiments of the present
disclosure will be set forth in the description that follows, and
in part will be obvious from the description, or may be learned by
the practice of such exemplary embodiments. These and other
features will become more fully apparent from the following
description and appended claims, or may be learned by the practice
of such exemplary embodiments as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
These and other features, aspects, and advantages of the present
disclosure will become better understood regarding the following
description, appended claims, and accompanying drawings.
FIG. 1 is an exploded view of a prosthetic socket system according
to an embodiment.
FIG. 2 is a cross-sectional view of the prosthetic socket system
shown in FIG. 1 according to an embodiment.
FIG. 3 is a detailed cross-sectional view of the prosthetic socket
system according to an embodiment.
FIG. 4 illustrates a method for utilizing a prosthetic socket
system according to an embodiment.
FIG. 5 is a cross-sectional view of a prosthetic socket system
according to another embodiment.
FIG. 6 is a cross-sectional view of a prosthetic socket system
according to another embodiment.
FIG. 7 is a cross-sectional view of a prosthetic socket system
according to another embodiment.
DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS
A better understanding of different embodiments of the disclosure
may be had from the following description read with the
accompanying drawings in which like reference characters refer to
like elements.
While the disclosure is susceptible to various modifications and
alternative constructions, certain illustrative embodiments are in
the drawings and are described below. It should be understood,
however, there is no intention to limit the disclosure to the
specific embodiments disclosed, but on the contrary, the intention
covers all modifications, alternative constructions, combinations,
and equivalents falling within the spirit and scope of the
disclosure.
For further ease of understanding the embodiments of an orthopedic
device as disclosed herein, a description of a few terms is
necessary. As used herein, the term "proximal" has its ordinary
meaning and refers to a location that is closer to the heart than
another location. Likewise, the term "distal" has its ordinary
meaning and refers to a location that is further from the heart
than another location. The term "posterior" also has its ordinary
meaning and refers to a location that is behind or to the rear of
another location. Lastly, the term "anterior" has its ordinary
meaning and refers to a location that is ahead of or to the front
of another location.
The terms "rigid," "flexible," and "resilient" may be used herein
to distinguish characteristics of portions of certain features of
the orthopedic device. The term "rigid" is intended to denote that
an element of the device is generally devoid of flexibility. On the
other hand, the term "flexible" is intended to denote that features
are capable of repeated bending such that the features may be bent
into retained shapes or the features do not retain a general shape,
but continuously deform when force is applied. The term "resilient"
is used to qualify such flexible features as generally returning to
an initial general shape without permanent deformation. As for the
term "semi-rigid," this term is used to connote properties of
elements that provide support and are free-standing; however, such
elements may have some degree of flexibility or resiliency.
It will be understood that unless a term is expressly defined in
this application to possess a described meaning, there is no intent
to limit the meaning of such term, either expressly or indirectly,
beyond its plain or ordinary meaning.
Any element in a claim that does not explicitly state "means for"
performing a specified function, or "step for" performing a
specific function is not to be interpreted as a "means" or "step"
clause as specified in 35 U.S.C. .sctn. 112, paragraph 6.
FIGS. 1-3 show a first embodiment of the prosthetic socket system
comprising a prosthetic socket system 100. As seen in FIGS. 1 and
2, the system 100 includes a socket 102 having an outer surface 110
and an opposing inner surface 108 defining a socket cavity 106. The
inner surface 108 is arranged as a close-ended cup with an open
proximal end and a closed distal end area. The open proximal end of
the inner surface 108 is adapted to receive a distal portion of the
residual limb 101 to be located in the socket cavity 106.
A liner 112 is adapted to be removably positioned within the socket
cavity 106 and to receive a residual limb 101 therein. The liner
112 can include a body that extends between a proximal end 114 and
a distal end area 116 and can comprise an air-impermeable
elastomeric material such as silicone, copolymer gel, polyurethane,
urethane, thermoplastic elastomer, RTV rubber, combinations
thereof, or any other appropriate material.
The liner 112 is typically donned on the residual limb 101 and the
limb 101 and the liner 112 are then inserted in the socket cavity
106 of the socket 102. The softer elastomer of the liner 112
adheres to the skin of the residual limb 101 frictionally to
thereby secure the residual limb 101 within the liner 112. The
liner 112, on the other hand, remains contained within the socket
cavity 106 after it has been fully inserted into the distal end
area of the socket cavity 106 by creating a seal between the socket
102 and the liner 112.
A seal may refer to a component of the system 100 that allows a
vacuum to be formed between the liner 112 and the socket 102. In
the illustrated embodiment, a seal element 118 can be associated
with the liner 112 to create a vacuum between the socket 102 and
the liner 112. Any pulling forces applied to the liner 112 will
result in a suction being created between the liner 112 and the
socket 102.
A substantially sealed volume 142 can be defined distally of the
seal element 118 and between at least a portion of the outer
surface 115 of the liner 112 and a corresponding portion of the
inner surface 108 of the socket 102, substantially isolating this
area from atmosphere.
A wicking material 128 is positionable in the substantially sealed
volume 142. As seen, the wicking material 128 can have a sock-like
configuration including a generally continuous sidewall 130, an
open top 132, and a closed bottom 134.
The wicking material 128 can be generally compressible, and
selectively removable from the system 100. For example, the wicking
material 128 can be selectively donned on the outer surface 115 of
the liner 112. The wicking material 128 can be positioned on the
liner 112 and then the liner 112 and the wicking material 128 can
be inserted in the socket cavity 106 of the socket 102. This
advantageously allows the wicking material 128 to be removed from
the prosthetic socket system 100 for hygienic purposes, for
replacement, for repair, or for any desired purpose.
Alternatively, the wicking material 128 can be removably attached
to the socket cavity 106 of the socket 102. In other embodiments,
the wicking material 128 can be bonded or fixedly attached to the
liner 112 or the socket cavity 106.
The wicking material 128 can comprise one or more porous materials
having one or more wicking properties. For example, the wicking
material 128 can comprise a woven material, a perforated material,
a sponge-like material, combinations thereof, or any other suitable
material. The wicking material 128 can comprise polyester, wool,
cotton, synthetic materials, natural materials, a sponge-like
material, combinations thereof, or any other suitable material.
As seen in FIG. 3, at least one cooling fluid 136 can be supplied
to the substantially sealed volume 142 and/or the wicking material
128 within the substantially sealed volume 142. The at least one
cooling fluid 136 is arranged to remove energy/heat from the liner
112 and/or residual limb 101 by absorbing and/or converting such
heat into other forms of energy for a cooling effect.
The at least one cooling fluid 136 can include water, deionized
water, substantially pure water, an alcohol, a dielectric fluid, a
solution, oil, a refrigerant, a glycol, a gel-like material,
combinations thereof, or any other suitable fluid. The at least one
cooling fluid 136 can include a single liquid or a solution or
mixture of a plurality of liquids. The at least one cooling fluid
136 can include a mixture of liquids, vapor, and/or gases. The at
least one cooling fluid 136 can be selected based on one or more
physical and/or chemical properties. For example, the at least one
cooling fluid may be selected based on boiling point, thermal
conductivity, specific heat, viscosity, freezing point, flash
point, corrosivity, toxicity, thermal stability, combinations
thereof, or any other suitable property.
During use, the temperature of the residual limb 101 within the
distal end area of the socket cavity 106 can increase until it
becomes greater than the temperature of the outer surface 115 of
the liner 112 wherein the wicking material 128 and the at least one
cooling fluid 136 are located.
When the temperature of the residual limb 101 is greater than the
at least one cooling fluid 136, heat/energy is transferred from the
residual limb 101 through the liner 122 and to the at least one
cooling fluid 136 until a thermal equilibrium is established, that
is the residual limb 101, the liner 112, and the at least one
cooling fluid 136 reach the same temperature. The direction of
energy transfer is always from the higher temperature body to the
lower temperature one. Thus, heat/energy is transferred from the
higher temperature residual limb 101 to the lower temperature of
the at least one cooling fluid 136, cooling the residual limb 101
and increasing the temperature of the at least one cooling fluid
136.
When the temperature of the at least one cooling fluid 136 reaches
and/or exceeds its boiling point, the at least one cooling fluid
136 within the substantially sealed volume 142 begins to boil. More
particularly, as the temperature of the at least one cooling fluid
136 increases, the energy transferred from the residual limb 101 is
absorbed by the molecules of the at least one cooling fluid 136.
This in turn causes the molecules to acquire additional kinetic
energy and increases molecular motion (vibrations and molecules
slipping past each other).
Eventually, when the temperature of the at least one cooling fluid
136 reaches and/or exceeds its boiling point, the molecular motion
becomes so intense that the forces of attraction between the
molecules are disrupted to the extent that at least some of the
molecules break free from the at least one cooling fluid 136 in
liquid form and become a gas or vapor which rises from the at least
one cooling fluid 136.
The latent heat of vaporization is the amount of energy absorbed by
the at least one cooling fluid 136 during this process of
vaporization. For example, if the at least one cooling fluid 136 is
pure water, and at 1 atm pressure, the cooling fluid 136 can absorb
and/or remove about 2200 Joules (0.52 calories) from the residual
limb 101 with each gram of boiled water. The boiling point of at
least one cooling fluid 136 can be selected to be lower than a
first temperature limit associated with the substantially sealed
volume 142, the distal end of the residual limb 101, and/or the
liner interface between the residual limb 101 and the liner 112 in
the area of the substantially sealed volume 142, activating the
system 100 or helping to prevent the residual limb 101 from
overheating. The boiling point of at least one cooling fluid 136
can be selected to be higher than a second temperature limit
associated with the substantially sealed volume 142, the distal end
of the residual limb 101, and/or the liner interface between the
residual limb 101 and the liner 112 in the area of the
substantially sealed volume 142, helping to prevent the residual
limb 101 from becoming too cold or deactivating the system 100.
The system can thus advantageously extract heat from the residual
limb 101 at least in part through the conversion of such heat to
latent heat of vaporization, providing the user a cooler more
comfortable fit, which, in turn, reduces sweating of the residual
limb 101 and the likelihood of friction-related injuries and skin
irritation. Furthermore, it does so without the need of expensive
and costly heat removal or drainage elements.
To permit expulsion of the gases or vapors rising from the boiling
cooling fluid 136 and/or purging of other fluids from the
substantially sealed volume 142, an aperture 120 can be defined by
the socket 102 that extends through the inner surface 108 and the
outer surface 110 of the socket 102. The substantially sealed
volume 142 can be in fluid communication with atmosphere external
to the socket 102 via the aperture 120. A valve 122 may be provided
separately or integrally with the aperture 120. The valve 122 can
be a one-way valve that selectively permits fluids to flow from the
substantially sealed volume 142 through the aperture 120 to
atmosphere external to the socket 102, but not in the other
direction.
It will be appreciated that by exhausting the gases or vapors from
the substantially sealed volume 142, additional heat or energy can
be removed from the residual limb or interface of the residual limb
101 and the liner 112 by relieving pressure buildup (e.g. kinetic
energy created by the release of the gases or vapors) within the
substantially sealed volume 142.
Optionally, a pump 124 (shown in FIGS. 1 and 2) may be in fluid
communication with the substantially sealed volume 142 via the
aperture 120. The pump 124 can create an elevated vacuum
environment in the substantially sealed volume 142. This can
beneficially enhance the purging or exhaustion of fluids from the
substantially sealed volume 142. It can also increase the
effectiveness of the system 100 in removing heat or energy from
residual limb 101 or the liner interface between the residual limb
101 and the liner 112. The pump 124 may comprise a manual, an
electric pump, a wet/dry pump, or any other suitable pump.
For instance, an elevated vacuum environment in the substantially
sealed volume 142, by lowering saturation vapor pressure, lowers
the boiling point of the at least one cooling fluid 136. The pump
124 can thus vary the boiling point of the at least one cooling
fluid 136. As such, the pump 124 can be operated to create an
elevated vacuum level within the substantially sealed volume 142
that lowers the boiling point of the at least one cooling fluid 136
below the ambient or surrounding temperature within the
substantially sealed volume 142, which, in turn, will cause the at
least one cooling fluid 136 to boil. The boiling point of at least
one cooling fluid 136 can be controlled (or selected) to be lower
or higher than one or more temperature limits associated with the
substantially sealed volume 142, the distal end of the residual
limb 101, and/or the liner interface between the residual limb 101
and the liner 112 in the area of the substantially sealed volume
142. This can help maintain the temperature of the residual limb
101 within a desired range and/or control the timing and/or level
of heat removal achieved by the at least one cooling fluid 136.
As discussed above, as the at least one cooling fluid 136 boils, it
removes or absorbs heat from its surroundings (e.g., the residual
limb 101 and the liner 112) by converting such heat into latent
heat of vaporization. Operation of the pump 124 can thus
advantageously produce a cooling effect for the user on demand or
when it is needed most. The pump 124 can also be advantageously
used to regulate the temperature of the residual limb 101 during
physical activities such as walking or sports.
Further, with a substantially constant flow of heat or energy from
the residual limb 101 and/or the liner 112 towards the at least one
cooling fluid and removal of the vapors or gases from the
substantially sealed volume 142 at the same time by the pump 124,
the at least one cooling fluid 136 can keep boiling and thereby
keep removing heat or energy from the residual limb 101 until the
at least one cooling fluid 136 is boiled away. This can
advantageously transfer heat or energy away from the residual limb
101 in a generally continuous flow without the insulating effect of
the socket 102 playing a significant role.
The pump 124 can be operated to create an elevated vacuum level
that moves the boiling point of the at least one cooling fluid 136
to a target boiling point that is selected to help maintain the
temperature of at least the distal end of the residual limb 101 in
the socket cavity 106 below a desired temperature.
It will be appreciated that the elevated vacuum environment
generated by the pump 124 can also increase the suction created
between the distal end area 116 of the liner 112 and the
corresponding inner surface 108 of the socket.
The elevated vacuum level or elevated vacuum environment
established by the pump 124 may be selected based on
characteristics of the user, the at least one cooling fluid 136,
and/or other factors. The pump 124 can pull a continuous or a
non-continuous vacuum in the substantially sealed volume 142. For
instance, the system 100 can include a controller arranged to
direct the pump 124 to establish the elevated vacuum environment in
the substantially sealed volume 142 based on feedback from at least
one pressure or temperature sensor.
Referring again to FIGS. 1 and 2, the pump 124 can be attached to
the socket 102. The pump 124 can be separate from the socket 102.
The pump 124 is arranged to be operated by the user's gait. For
instance, the pump 124 can be connected to a prosthetic foot and
include a conduit in fluid communication with the aperture 120. The
pump 124 is arranged to pull a vacuum in the substantially sealed
volume 142 in step phase, and to expel gases or vapors and
associated pressure into the atmosphere in swing phase.
The pump 124 can thus utilize the motion of the prosthetic foot to
boil the at least one cooling fluid 136 and remove heat or energy
from the residual limb 101 or the interface between the residual
limb 101 and the liner 112, for a cooling effect. Cooling occurs
when the user is ambulating. This is advantageous because warming
up and sweating of the residual limb 101 rarely occurs unless some
activity is occurring. Other examples of suitable gait actuated
pumps are found in U.S. patent application Ser. Nos. 13/873,394 and
13/873,315, which are incorporated herein by reference in their
entirety.
The one-way valve 122 can be integral to the pump 124. The pump 124
can be fluidly connected to the one-way valve 122 via a tube 126.
Hoses, fittings, or other connection mechanisms may be situated
between the pump 124, the one-way valve 122, and/or the aperture
120. The valve 122 can have any suitable construction and may take
the form of an electronic valve, a duck-billed valve, a slit valve,
a spring biased element check valve, or any other suitable type of
valve. The valve 122 can be selected for use based upon an
actuation pressure. The valve 122 can be a two-way valve actuated
by a controller, the pump 124, pressure differential, or another
trigger. The pump 124 can supply the at least one cooling fluid 136
to the substantially sealed volume 142 via the aperture 120 and the
valve 122 when the valve 122 is a two-way valve.
The wicking material 128 includes a cross-sectional area and
surface area that can carry, pick up, and/or distribute the at
least one cooling fluid 136, facilitating boiling of the at least
one cooling fluid 136.
The wicking material 128 can include one or a plurality of layers.
For instance, the wicking material 128 can include a first layer
and a second layer spaced from the first layer. A region can be
defined between the first and second layers. The at least one
cooling fluid 136 can be disposed within the region of the wicking
material 128 and the pores of the wicking material 128 can be in
fluid communication with the region.
The wicking material 128 can have any suitable configuration but is
described having a sock-like configuration. For instance, the
wicking material 128 has an open-ended sleeve configuration. The
wicking material 128 can be an elongate strip of material arranged
to be wrapped around the liner 112. The wall 130 of the wicking
material 128 can be continuous.
The wall 130 of the wicking material 128 can be non-continuous
(e.g. including one or more openings or slots defined therein. The
wall 130 of the wicking material 128 can include a plurality of
strips that are spaced apart and extending between a rim defining
the open top 132 and the closed bottom 134 of the wicking material
128.
The wicking material 138 can substantially fill all or a portion of
the substantially sealed volume 136. The wicking material 138 can
extend through some or all of a gap defined between the inner
surface 108 of the socket 102 and the outer surface 115 of the
liner 112. Alternatively, the wicking material 128 can be omitted.
For instance, the at least one cooling fluid 136 can be supplied
directly to the substantially sealed volume without the wicking
material 128.
The at least one cooling fluid 136 can be supplied to the wicking
material 128 via any suitable technique. The wicking material 128
can be wetted with the at least one cooling fluid 136 before
positioning the wicking material 128 in the substantially sealed
volume 142. The at least one cooling fluid 136 can be sprayed onto
the wicking material 128. The at least one cooling fluid 136 can be
supplied to the wicking material 128 via the aperture 120 or
another port defined in the socket 102.
Alternatively, the at least one cooling fluid 136 can be located
within a plurality of beads, particles, or fibers attached and/or
carried by the wicking material 128. For instance, the beads can be
arranged to burst when a target temperature is reached or when they
are squeezed between the liner 112 and the inner surface 108 of the
socket 102.
The at least one cooling fluid 136 can include different cooling
fluids arranged for different activities and/or conditions. For
instance, the at least one cooling fluid 136 can include a cooling
fluid adapted for sporting activities. The at least one cooling
fluid 136 can include a cooling fluid adapted for winter or summer
type conditions.
It will be appreciated that while one aperture 120 is described in
the sidewall of the socket 102, in other embodiments, any suitable
number of apertures may be located in any suitable manner within
the socket cavity 106. For example, a plurality of apertures may be
provided axially and circumferentially spaced along the socket
cavity 106. In other embodiments, the aperture 120 may be formed
through the distal end of the socket.
The seal element 118 can have any suitable configuration. For
example, the seal element 118 may be tapered outwardly from its
distal end towards its proximal end to facilitate insertion of the
liner 112 into the socket cavity 106 and tends to resist outward
movement of the liner 112 from the socket cavity 106 of the socket
102.
Also, the form of the seal element 118 can provide an increased
sealing force between the liner 112 and the socket 102 when the
liner 112 is moved in a direction towards the distal end of the
liner 112 when subjected to a pressure differential where a lower
pressure exists towards the distal side of the seal as compared to
the proximal side thereof. Other examples of suitable seal elements
are found in U.S. Pat. Nos. 8,308,817; 8,097,043; 8,052,760;
8,034,120; 8,372,159; 8,372,159; and 8,894,719, and U.S. patent
application Ser. Nos. 13/589,415; 13/748,891; 13/765,127;
13/826,748; 14/187,681; 14/203,715; and 14/281,424, each of which
are incorporated herein by reference in their entirety.
In other embodiments, the inner surface of the socket 102 can
include an annular seal or flange secured thereto or the seal
element may be omitted.
The liner 112 can be soft and at least radially distensible
elastically. The liner 112 may also be elastically distensible
axially or may have limited axial elasticity. The liner 112 may be
thickened to provide a cushioning effect between the residual limb
101 and the socket 102 and may be used for both trans-tibial (TT)
amputees as well as trans-femoral (TF) amputees. That is, the liner
112 may be utilized for applications above the knee or below the
knee of the amputee. Exemplary liners are found in U.S. Pat. Nos.
6,136,039; 6,626,952; 6,485,776; 6,706,364; 7,001,563; and
7,118,602, each of which are incorporated herein by reference in
their entirety.
The socket 102 can exhibit any suitable configuration. The socket
102 can be constructed of any suitable materials. The socket 102
can be cast, molded, laminated, or otherwise formed of synthetic
and/or reinforced components. The socket 102 is described having a
unitary construction forming a shell but can include an assembly of
a plurality of components. An example of a suitable socket is found
in U.S. Pat. Nos. 5,885,509 and 7,105,122, which are incorporated
herein in their entirety by reference.
The socket 102 can be structurally rigid, structural, load-bearing,
and can provide a user with the security as expected under normal
usage conditions as the volume of the socket 102 will not change
under a load. The socket cavity 106 may have a generally
cylindrical or conical shape. Alternatively, the socket cavity 106
can have a customized shape that substantially corresponds to the
general shape of the residual limb of a particular user.
The socket 102 is preferably air impervious. The socket 102 may
have a socket adapter 104 located at the distal portion of the
socket shell 102 for connecting the socket 102 to a prosthetic limb
(not shown) such as a prosthetic knee, ankle, or elbow joint. The
adapter 104 may be any suitable conventional adapter, such as a
pyramid connection or a threaded connection.
A method of using the prosthetic socket system 100 according to an
embodiment will now be described in relation to FIG. 4. The method
400 includes a step 401 of positioning an air-impermeable liner on
a lower part of the residual limb. With the liner positioned on the
residual limb, the method 400 includes a step 403 of positioning
the wicking material on the outside of the liner. The method 400
includes a step 405 of adding or supplying (e.g., wetting,
spraying, soaking, etc.) one or more cooling fluids to the wicking
material. The wicking material can be wetted with the cooling
fluids before or after the wicking material is positioned on the
liner.
The method 400 includes a step 407 of positioning the lower part of
the residual limb, the liner, and the wetted wicking material in
the socket cavity of the socket. The wicking material is positioned
in a substantially sealed volume defined between at least a portion
of the liner and a corresponding portion of the socket. Finally,
the method 400 includes a step 409 of creating a vacuum within the
substantially sealed volume such that the one or more cooling
fluids boil, thereby drawing heat/energy away from the residual
limb for a cooling effect.
In an alternative embodiment, the wicking material can be omitted.
For example, the one or more cooling fluids can be supplied between
the liner and the socket without the wicking material.
Another exemplary embodiment of a prosthetic socket system 500 is
shown in FIG. 5. This embodiment is similar to system 100 except
that the socket 502 includes a second aperture 538 in communication
with a substantially sealed volume 542. The socket 502 has an outer
surface 510 and an inner surface 508 defining a socket cavity 506.
A socket adaptor 504 located at the distal end of the socket 502
for connecting the socket 502 to a prosthetic limb.
A liner 512 is adapted to be removably positioned within the socket
cavity 506 and to receive a residual limb 501 therein. The liner
512 can include a body that extends between a proximal end 514 and
a distal end area 516.
The substantially sealed volume 542 is defined between at least a
portion of the outer surface 515 of the liner 512 and a
corresponding portion of the inner surface 508 of the socket 502.
In the illustrated embodiment, a seal element 518 is associated
with the liner 512 that at least in part defines the substantially
sealed volume 542.
Similar to the previously described embodiments, a wicking material
528 and/or at least one cooling fluid are positionable in the
substantially sealed volume 542. The wicking material 528 has a
sidewall 530, an open top, and a closed bottom 534. The at least
one cooling fluid is arranged to selectively boil within the
substantially sealed volume 542 such that heat from the residual
limb 501 is converted into latent heat of vaporization, extracting
the heat from the residual limb for a cooling effect. This
advantageously reduces sweating of the limb and the likelihood of
friction-related injuries and skin irritation. Furthermore, it does
so without the need of expensive and costly heat removal and/or
draining elements.
A first aperture 520 is defined in the socket 502 that extends
through the inner surface 508 and the outer surface 510 of the
socket 502. The substantially sealed volume 542 can be in fluid
communication with the atmosphere external to the socket 102 via
the first aperture 520. A first one-way valve 522 selectively
allows fluids to be expelled from the substantially sealed volume
542 through the first aperture 520 to atmosphere, but not in the
other direction.
A pump 524 can be fluidly connected to the first one-way valve 522
via a tube 526. The pump 524 can be arranged to create an elevated
vacuum environment in the substantially sealed volume 542. This can
beneficially enhance the purging or exhaustion of fluids from the
substantially sealed volume 542. It can also increase the
effectiveness of the system 500 in removing heat or energy from
residual limb 501 or the liner interface between the residual limb
501 and the liner 512.
The second aperture 538 is also defined through the inner and outer
surfaces 508, 510 of the socket 502. The second aperture 538 can be
coupled to a second valve 540 adapted to at least allow the at
least one cooling fluid to be supplied and/or replenished within
the substantially sealed volume 542. This advantageously allows the
at least one cooling fluid to be supplied and/or replenished to the
wicking material after the prosthetic socket system 500 is
positioned on the residual limb, without having to remove
components from the system 500, making the system 500 easier and
more comfortable to use. The second valve 540 can be a one-way
valve or a two-way valve.
Another exemplary embodiment of a prosthetic socket system 600 is
shown in FIG. 6. This embodiment is similar to the embodiment of
FIGS. 1-3 except that there is no seal element associated with the
liner 612. As seen, a socket 602 includes an inner surface 608
defining a socket cavity and a liner 612 is adapted to be removably
positioned within the socket cavity of the socket 602. The liner
612 is adapted to receive a residual limb 601 therein.
A prosthetic sleeve 640 is positioned on the residual limb 601 and
an outer surface 610 of the socket 602. The prosthetic sleeve 640
can create a seal between the proximal end of the socket 602 and
the liner 612, as disclosed in U.S. Pat. No. 8,097,043,
incorporated by reference in its entirety. A portion of the
prosthetic sleeve 640 can be rolled over the brim of the socket
602. An example of a suitable prosthetic sleeve is found in U.S.
Pat. No. 6,592,539, the entirety of which is incorporated herein by
reference.
The substantially sealed volume 642 can be defined between at least
the seal formed by the prosthetic sleeve 640, the outer surface 615
of the liner 612, and the inner surface 608 of the socket 602.
Similar to the system 100, a wicking material 628 and/or at least
one cooling fluid are positionable in the substantially sealed
volume 642. The at least one cooling fluid is arranged to
selectively boil within the substantially sealed volume 642 such
that heat from the residual limb 601 is converted into latent heat
of vaporization.
An aperture 620 is defined in the socket 602 that extends through
the inner surface 608 and the outer surface 610 of the socket 602.
The substantially sealed volume 642 can be in fluid communication
with the atmosphere external to the socket 602 via the aperture
620. A one-way valve 622 selectively allows fluids to be expelled
from the substantially sealed volume 642 through the aperture 620
to atmosphere, but not in the other direction. A pump 624 can be
fluidly connected to the one-way valve 622 via a tube 626. The pump
624 can be arranged to create an elevated vacuum environment in the
substantially sealed volume 642. This can beneficially enhance the
purging or exhaustion of fluids from the substantially sealed
volume 642. It can also increase the effectiveness of the system
600 in removing heat or energy from residual limb 601 or the liner
interface between the residual limb 601 and the liner 612.
Another exemplary embodiment of a prosthetic socket system 700 is
shown in FIG. 7. This embodiment is similar to the embodiment of
FIGS. 1-3 except that the seal element 718 is associated with the
liner 712. A socket 702 includes an inner surface 708 defining a
socket cavity and a liner 712 is adapted to be removably positioned
within the socket cavity of the socket 702. The liner 712 is
adapted to receive a residual limb 701 therein.
The socket 702 includes a flexible brim 742 defining a seal element
718 arranged to form a seal between the liner 712 and the proximal
end of the socket 702. An example of a suitable seal element on a
socket is found in U.S. patent application Ser. No. 14/457,379, the
entirety of which is incorporated herein by reference.
As seen, the substantially sealed volume 742 can be defined between
the seal element 718 on the socket 702, the outer surface 715 of
the liner 712, and the inner surface 708 of the socket 702. Similar
to the previously described systems, a wicking material 728 and/or
at least one cooling fluid are positionable in the substantially
sealed volume 742. The at least one cooling fluid is arranged to
selectively boil within the substantially sealed volume 742 such
that heat from the residual limb 701 is converted into latent heat
of vaporization for a cooling effect.
An aperture 720 is defined in the socket 702 that extends through
the inner surface 708 and the outer surface 710 of the socket 702.
The substantially sealed volume 742 can be in fluid communication
with the atmosphere external to the socket 702 via the aperture
720. A one-way valve 722 selectively allows fluids to be expelled
from the substantially sealed volume 742 through the aperture 720
to atmosphere, but not in the other direction. A pump 724 can be
fluidly connected to the one-way valve 722 via a tube 726. The pump
724 can be arranged to create an elevated vacuum environment in the
substantially sealed volume 742.
While the disclosure is susceptible to various modifications and
alternative constructions, certain illustrative embodiments are in
the drawings and are described below. It should be understood,
however, there is no intention to limit the disclosure to the
specific embodiments disclosed, but on the contrary, the intention
covers all modifications, alternative constructions, combinations,
and equivalents falling within the spirit and scope of the
disclosure.
* * * * *
References